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Re: hyperopia post# 685053

Monday, 04/15/2024 7:46:47 AM

Monday, April 15, 2024 7:46:47 AM

Post# of 687940
This part I have and still agree is possible, except for the Flaskworks process occurring within that time frame. Reimbursement might require some time (two to three months) after approval. Imo.

There are three independent timelines; one for commercial approval of DCVax, one for NICE reimbursement, and one for Flaskworks process approval. They will likely occur in that order, and potentially reasonably close together, so it’s not necessarily inconsistent with a 150-day approval process for DCVax. — hyperopia




I don’t agree with Senti that marketing approval for DCVax-l is now awaiting Eden approval. That would be a bait and switch. Placing delays back into the hands of NWBO from the hands of regulators. IMO.

Your alternative opinion they will wait to use Eden instead of artisan following initial approval is also pie in the sky. To suggest the NICE reimbursement process is not currently running parallel is patronizing. To suggest validation of Eden can occur in a short period of time to avoid commercial artisan production would be inconsiderate to patients, imo. To suggest more brain surgeons can’t switch from paraffin tumor preservation to frozen preservation and transport quickly, is an insult. IMO

I know some here can’t wait for technologies like Eden, but the artisan process is happening as we speak, can be ramped after approval, and displaced after validation of Eden occurs down the road. Imo.

Moreover, there are interim reimbursement sources if the reimbursement process from NICE were to need more than three months after approval to decide. Imo.
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